Viewing Study NCT05061602


Ignite Creation Date: 2025-12-25 @ 4:02 AM
Ignite Modification Date: 2025-12-26 @ 2:56 AM
Study NCT ID: NCT05061602
Status: COMPLETED
Last Update Posted: 2023-07-27
First Post: 2021-09-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Sponsor: Tülay Çevik Saldıran
Organization:

Study Overview

Official Title: Biomechanical and Viscoelastic Properties of Plantar Fascia in Diabetes Mellitus
Status: COMPLETED
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DMumecPRO
Brief Summary: In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.
Detailed Description: Chronic diabetes can lead to ulceration in the plantar region and may result in amputation. Diabetes-related foot ulcerations are one of the most challenging complications of diabetes mellitus. Myotonometry, a technique to measure dynamic stiffness is preferred due to its noninvasiveness, easy employability, and rapid investigation. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. Increased plantar tissue stiffness is thought to alter the distribution of tensile stresses in the plantar soft tissues during gait. Combined with a reduction in plantar tissue thickness, these changes could collectively decrease the mechanical loads required to initiate soft tissue breakdown and thus lead to foot ulceration formation. Diabetes mellitus is a significant risk factor for falls in adults and is associated with an increase in fear of falling. Microvascular complications associated with DM result in multiple impairments including sensory deficits and muscle weakness due to peripheral neuropathy, loss of visual acuity due to retinopathy, and impaired postural control and falls due to vestibulopathy. The prevalence of falls and fear of falling are significantly higher in adults with diabetes mellitus. Assessment of mechanical properties of plantar tissues can aid in the early diagnosis of ulceration. In this study, an attempt has been made to analyze the changes in soft tissue biomechanical properties of the plantar surface in diabetes. The second aim of this study was to explore the relationships between fear of falling, physical performance, and plantar stiffness in patients with diabetes.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: